Effect of itraconazole, food, and ethnic origin on the pharmacokinetics of ivosidenib in healthy subjects

Purpose To assess the effect of ethnicity, food, and itraconazole (strong CYP3A4 inhibitor) on the pharmacokinetics of ivosidenib after single oral doses in healthy subjects. Methods Three phase 1 open-label studies were performed. Study 1: Japanese and Caucasian subjects received single doses of 25...

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Vydané v:	European journal of clinical pharmacology Ročník 75; číslo 8; s. 1099 - 1108
Hlavní autori:	Dai, David, Yang, Hua, Nabhan, Salah, Liu, Hua, Hickman, Denice, Liu, Guowen, Zacher, Jeffrey, Vutikullird, Apinya, Prakash, Chandra, Agresta, Samuel, Bowden, Chris, Fan, Bin
Médium:	Journal Article
Jazyk:	English
Vydavateľské údaje:	Berlin/Heidelberg Springer Berlin Heidelberg 01.08.2019 Springer Nature B.V
Predmet:	Administration, Oral Adult Antifungal agents Antineoplastic Agents - administration & dosage Antineoplastic Agents - adverse effects Antineoplastic Agents - pharmacokinetics Area Under Curve Asian Continental Ancestry Group Biomedical and Life Sciences Biomedicine Clinical trials Cross-Over Studies Cytochrome P-450 CYP3A Inhibitors - pharmacology Dehydrogenases Dose-Response Relationship, Drug Drug dosages Drug Interactions - ethnology Ethnicity FDA approval Female Food Food-Drug Interactions - ethnology Gene expression Glycine - administration & dosage Glycine - adverse effects Glycine - analogs & derivatives Glycine - pharmacokinetics Healthy Volunteers Humans Itraconazole Itraconazole - administration & dosage Itraconazole - pharmacology Leukemia, Myeloid, Acute - drug therapy Long QT Syndrome - diagnosis Long QT Syndrome - epidemiology Long QT Syndrome - etiology Male Metabolism Middle Aged Minority & ethnic groups Mutation Patients Pharmaceuticals Pharmacokinetics Pharmacokinetics and Disposition Pharmacology/Toxicology Pyridines - administration & dosage Pyridines - adverse effects Pyridines - pharmacokinetics Isocitrate dehydrogenase 1 inhibitor CYP3A4 inhibitors Drug interaction Food effect Pharmacokinetics Ivosidenib
ISSN:	0031-6970, 1432-1041, 1432-1041
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